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NCT00003955 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-02-14

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma * No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site * Metastatic tumors of parameningeal sites eligible * Bidimensionally measurable disease * No positive cerebrospinal fluid cytology or multiple intracranial metastases * Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy: * Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy * Tumor that touches or displaces the spinal cord * Evidence of intracranial primary tumor extension * Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate * Requires emergency radiotherapy * Lab values are consistent with disseminated intravascular coagulation PATIENT CHARACTERISTICS: Age: * Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients) * 10 to 49 (embryonal histology patients) Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Absolute neutrophil count greater than 1,000/mm\^3\* * Platelet count greater than 150,000/mm\^3\* NOTE: \*Unless there is tumor involvement of bone marrow Hepatic: * Bilirubin less than 1.5 mg/dL * PT, PTT, and fibrinogen less than 1.5 times upper limit of normal Renal: * Creatinine less than 1.2 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior steroids allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy Surgery: * No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis
healthy Volunteers
false
maximum Age
49 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
interventions
  1. name
    dactinomycin
    type
    BIOLOGICAL
  2. name
    filgrastim
    type
    BIOLOGICAL
  3. name
    pegfilgrastim
    type
    BIOLOGICAL
  4. name
    sargramostim
    type
    BIOLOGICAL
  5. name
    cyclophosphamide
    type
    DRUG
  6. name
    irinotecan hydrochloride
    type
    DRUG
  7. name
    vincristine sulfate
    type
    DRUG
  8. name
    radiation therapy
    type
    RADIATION
Study design
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
77
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Event Free Survival
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
detailed Description
OBJECTIVES: * Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine. * Determine the toxic effects of this regimen in these patients. * Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response. * Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy. * Determine the pharmacokinetics of irinotecan and vincristine in these patients. OUTLINE: * Upfront window therapy: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B. * Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22. * Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A. Patients who do not receive upfront window irinotecan/vincristine therapy are treated with standard therapy. * Standard therapy: Patients receive vincristine IV over 1 minute weekly on weeks 0-13, 15-19, 23-27, 29, 32-35, 38, and 41; dactinomycin IV over 1 minute weekly on weeks 0, 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients without evidence of intracranial extension receive radiotherapy once daily, 5 days a week, during weeks 15-22. Patients with evidence of intracranial extension, or who require emergency radiotherapy, receive radiotherapy during weeks 0-6. Dactinomycin is withheld during radiotherapy. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover. Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover. Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.
Source references
references
  1. citation
    Soft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22. doi: 10.1200/JCO.2005.01.9497.
    pmid
    16849756
    type
    BACKGROUND
  2. citation
    Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH; Children's Oncology Group. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. doi: 10.1200/JCO.2006.07.1720.
    pmid
    17264331
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        /NCT00003958">D9803</a>) confirmed these observations.[<a href="#cit/section_1.70">70</a>] Analysis of 38 patients enrolled in the COG <a href="/clinicaltrials/NCT00003955">D9802 (NCT00003955)</a> low-risk study determined that fusion-positive, low-risk patients should be treated as intermediate risk.[<a href="#cit/section_1.71">
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        /a>) confirmed these observations.[<a href="#cit/section_1.70">70</a>] Analysis of 38 patients enrolled in the COG <a href="/clinicaltrials/NCT00003955">D9802 (NCT00003955)</a> low-risk study determined that fusion-positive, low-risk patients should be treated as intermediate risk.[<a href="#cit/section_1.71">71</a>]</p>
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        domyosarcoma that was metastatic to the bone marrow. These patients were enrolled in one of four COG rhabdomyosarcoma clinical trials (<a href="/clinicaltrials/NCT00003955">D9802</a>, <a href="/clinicaltrials/NCT00003958">D9803</a>, <a href="/clinicaltrials/NCT00354744">ARST0431</a>, and <a href="/clinicaltrials/NCT01055314">ARST
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        .[<a href="#cit/section_6.35">35</a>] <p id="_2182" tabindex="-1">Patients with lung metastases who were enrolled in four COG studies (<a href="/clinicaltrials/NCT00003955">D9802</a>, <a href="/clinicaltrials/NCT00003958">D9803</a>, <a href="/clinicaltrials/NCT01055314">ARST08P1</a>, and <a href="/clinicaltrials/NCT00354744">ARST
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        exact text
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        isk orbital rhabdomyosarcoma (mostly tumors with alveolar histology that were treated with more intensive intermediate-risk protocols [<a href="/clinicaltrials/NCT00003955">D9802</a>, <a href="/clinicaltrials/NCT00003958">D9803</a> and <a href="/clinicaltrials/NCT00354835">ARST0531</a>]), had 5-year EFS and OS rates of 88.5% (95%
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      source title
      Childhood Rhabdomyosarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 11, 2025
        datetime
        2025-04-11T12:00:00Z
        display
        April 11, 2025

    Preserved source evidence · Not medical advice